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ID

21153

Descrição

Cell Therapy in Chronic Ischemic Heart Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00362388

Link

https://clinicaltrials.gov/show/NCT00362388

Palavras-chave

Versões (1)
  1. 12/04/2017 12/04/2017 -
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12 de abril de 2017

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Ischemic Heart Disease NCT00362388

    Inglês

    Eligibility Ischemic Heart Disease NCT00362388

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (cad) referred for cabg.
    Descrição

    Diffuse disease of coronary artery severe chronic | Coronary Artery Disease Vessel atherosclerotic multiple | Coronary Artery Bypass Surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1299384
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0205191
    UMLS CUI [2,1]
    C1956346
    UMLS CUI [2,2]
    C0005847
    UMLS CUI [2,3]
    C0333482
    UMLS CUI [2,4]
    C0439064
    UMLS CUI [3]
    C0010055
    echocardiogram-assessed lvef between 25 and 55% (simpson's rule).
    Descrição

    Left ventricular ejection fraction Echocardiography

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0428772
    UMLS CUI [1,2]
    C0013516
    angina (or equivalent) functional class ii to iv (canadian cardiovascular society) despite maximally tolerated medical therapy.
    Descrição

    Angina Pectoris Canadian Cardiovascular Society classification | Therapeutic procedure Maximum Tolerated Dose

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0002962
    UMLS CUI [1,2]
    C1277207
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0752079
    abnormal myocardial perfusion tests:
    Descrição

    Myocardial perfusion study Abnormal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0841688
    UMLS CUI [1,2]
    C0205161
    i. cardiac scintigraphy ii. magnetic resonance imaging iii. dobutamine-atropine stress-echocardiogram
    Descrição

    Scintigraphy cardiac | Magnetic Resonance Imaging | Echocardiography, Stress, Dobutamine | Atropine Echocardiography, Stress

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0034606
    UMLS CUI [1,2]
    C0018787
    UMLS CUI [2]
    C0024485
    UMLS CUI [3]
    C0949700
    UMLS CUI [4,1]
    C0004259
    UMLS CUI [4,2]
    C0920208
    non-candidates for a percutaneous coronary intervention (pci) due to any of the following:
    Descrição

    Percutaneous Coronary Intervention

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1532338
    i. high risk lesion ii. extensive lesion iii. diffuse, small vessel disease
    Descrição

    Lesion High risk | Extensive Stage Lesion | Small-vessel disease Diffuse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0332167
    UMLS CUI [2]
    C1333487
    UMLS CUI [3,1]
    C3810309
    UMLS CUI [3,2]
    C0205219
    non-candidates for a complete cabg, or candidates for a complete cabg in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement.
    Descrição

    Coronary Artery Bypass Surgery Complete | Graft failure Probability High | Severity of illness | Involvement Small-vessel disease Diffuse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0010055
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [2,1]
    C1262018
    UMLS CUI [2,2]
    C0033204
    UMLS CUI [2,3]
    C0205250
    UMLS CUI [3]
    C0521117
    UMLS CUI [4,1]
    C1314939
    UMLS CUI [4,2]
    C3810309
    UMLS CUI [4,3]
    C0205219
    to provide a signed, written informed consent, according to the national guidelines for clinical trials.
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    severe valve heart disease requiring surgical repair.
    Descrição

    Heart valve disease Severe | Surgical repair Patient need for

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018824
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0374711
    UMLS CUI [2,2]
    C0686904
    serologic diagnostic of chagas' disease.
    Descrição

    Chagas Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0041234
    symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
    Descrição

    Heart failure Symptoms | Etiology aspects Ischemic | Myocardial Ischemia Absent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [2,1]
    C0015127
    UMLS CUI [2,2]
    C0475224
    UMLS CUI [3,1]
    C0151744
    UMLS CUI [3,2]
    C0332197
    malignant ventricular arrhythmias (like vt), unless an icd have been placed.
    Descrição

    Ventricular arrhythmia Malignant | Tachycardia, Ventricular | Implantable defibrillator Placement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0085612
    UMLS CUI [1,2]
    C0205282
    UMLS CUI [2]
    C0042514
    UMLS CUI [3,1]
    C0162589
    UMLS CUI [3,2]
    C0589567
    any acute coronary syndrome in the past 3 months.
    Descrição

    Acute Coronary Syndrome

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0948089
    end-stage renal disease requiring maintenance dialysis.
    Descrição

    Kidney Failure, Chronic | Maintenance Dialysis Patient need for

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0022661
    UMLS CUI [2,1]
    C0024501
    UMLS CUI [2,2]
    C0011946
    UMLS CUI [2,3]
    C0686904
    history of neoplasia.
    Descrição

    Neoplastic disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1882062
    drug or alcohol abuse.
    Descrição

    Substance Use Disorders

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    life expectancy below 2 years.
    Descrição

    Life Expectancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    enrollment in any cell therapy trial in the past 2 years.
    Descrição

    Study Subject Participation Status | Cell Therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0302189
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    Similar models

    Eligibility Ischemic Heart Disease NCT00362388

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diffuse disease of coronary artery severe chronic | Coronary Artery Disease Vessel atherosclerotic multiple | Coronary Artery Bypass Surgery
    Item
    diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (cad) referred for cabg.
    boolean
    C1299384 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0205191 (UMLS CUI [1,3])
    C1956346 (UMLS CUI [2,1])
    C0005847 (UMLS CUI [2,2])
    C0333482 (UMLS CUI [2,3])
    C0439064 (UMLS CUI [2,4])
    C0010055 (UMLS CUI [3])
    Left ventricular ejection fraction Echocardiography
    Item
    echocardiogram-assessed lvef between 25 and 55% (simpson's rule).
    boolean
    C0428772 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    Angina Pectoris Canadian Cardiovascular Society classification | Therapeutic procedure Maximum Tolerated Dose
    Item
    angina (or equivalent) functional class ii to iv (canadian cardiovascular society) despite maximally tolerated medical therapy.
    boolean
    C0002962 (UMLS CUI [1,1])
    C1277207 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0752079 (UMLS CUI [2,2])
    Myocardial perfusion study Abnormal
    Item
    abnormal myocardial perfusion tests:
    boolean
    C0841688 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    Scintigraphy cardiac | Magnetic Resonance Imaging | Echocardiography, Stress, Dobutamine | Atropine Echocardiography, Stress
    Item
    i. cardiac scintigraphy ii. magnetic resonance imaging iii. dobutamine-atropine stress-echocardiogram
    boolean
    C0034606 (UMLS CUI [1,1])
    C0018787 (UMLS CUI [1,2])
    C0024485 (UMLS CUI [2])
    C0949700 (UMLS CUI [3])
    C0004259 (UMLS CUI [4,1])
    C0920208 (UMLS CUI [4,2])
    Percutaneous Coronary Intervention
    Item
    non-candidates for a percutaneous coronary intervention (pci) due to any of the following:
    boolean
    C1532338 (UMLS CUI [1])
    Lesion High risk | Extensive Stage Lesion | Small-vessel disease Diffuse
    Item
    i. high risk lesion ii. extensive lesion iii. diffuse, small vessel disease
    boolean
    C0221198 (UMLS CUI [1,1])
    C0332167 (UMLS CUI [1,2])
    C1333487 (UMLS CUI [2])
    C3810309 (UMLS CUI [3,1])
    C0205219 (UMLS CUI [3,2])
    Coronary Artery Bypass Surgery Complete | Graft failure Probability High | Severity of illness | Involvement Small-vessel disease Diffuse
    Item
    non-candidates for a complete cabg, or candidates for a complete cabg in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement.
    boolean
    C0010055 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C1262018 (UMLS CUI [2,1])
    C0033204 (UMLS CUI [2,2])
    C0205250 (UMLS CUI [2,3])
    C0521117 (UMLS CUI [3])
    C1314939 (UMLS CUI [4,1])
    C3810309 (UMLS CUI [4,2])
    C0205219 (UMLS CUI [4,3])
    Informed Consent
    Item
    to provide a signed, written informed consent, according to the national guidelines for clinical trials.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Heart valve disease Severe | Surgical repair Patient need for
    Item
    severe valve heart disease requiring surgical repair.
    boolean
    C0018824 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0374711 (UMLS CUI [2,1])
    C0686904 (UMLS CUI [2,2])
    Chagas Disease
    Item
    serologic diagnostic of chagas' disease.
    boolean
    C0041234 (UMLS CUI [1])
    Heart failure Symptoms | Etiology aspects Ischemic | Myocardial Ischemia Absent
    Item
    symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
    boolean
    C0018801 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0015127 (UMLS CUI [2,1])
    C0475224 (UMLS CUI [2,2])
    C0151744 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Ventricular arrhythmia Malignant | Tachycardia, Ventricular | Implantable defibrillator Placement
    Item
    malignant ventricular arrhythmias (like vt), unless an icd have been placed.
    boolean
    C0085612 (UMLS CUI [1,1])
    C0205282 (UMLS CUI [1,2])
    C0042514 (UMLS CUI [2])
    C0162589 (UMLS CUI [3,1])
    C0589567 (UMLS CUI [3,2])
    Acute Coronary Syndrome
    Item
    any acute coronary syndrome in the past 3 months.
    boolean
    C0948089 (UMLS CUI [1])
    Kidney Failure, Chronic | Maintenance Dialysis Patient need for
    Item
    end-stage renal disease requiring maintenance dialysis.
    boolean
    C0022661 (UMLS CUI [1])
    C0024501 (UMLS CUI [2,1])
    C0011946 (UMLS CUI [2,2])
    C0686904 (UMLS CUI [2,3])
    Neoplastic disease
    Item
    history of neoplasia.
    boolean
    C1882062 (UMLS CUI [1])
    Substance Use Disorders
    Item
    drug or alcohol abuse.
    boolean
    C0038586 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy below 2 years.
    boolean
    C0023671 (UMLS CUI [1])
    Study Subject Participation Status | Cell Therapy
    Item
    enrollment in any cell therapy trial in the past 2 years.
    boolean
    C2348568 (UMLS CUI [1])
    C0302189 (UMLS CUI [2])
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